Cleared Traditional

RADI-BIOPSY DEVICE (K850605) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K850605 · Radiplast AB · Gastroenterology & Urology device
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Aug 1985
Decision
175d
Days
Class 2
Risk

K850605 is an FDA 510(k) clearance for the RADI-BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Radiplast AB (Kalamazoo, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 175 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiplast AB devices

Submission Details

510(k) Number K850605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date August 09, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 130d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 95
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K850605.
BARD BIOPTY BIOPSY SYSTEM
K871390 · C.R. Bard, Inc. · Jun 1987
SOFT TISSUE BIOPSY NEEDLE
K870785 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · Quinton, Inc. · Aug 1978
PROSTATE BIOPSY NEEDLE
K770122 · Cook, Inc. · Jan 1977